SCRS Site Management Module E6(R2) and (R3) Update Supplement Essential Documents for a Clinical Study Section 8: The sponsor and investigatorinstitution should maintain a record of the location(s) of their respective essential documents
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Presentation Transcript
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SCRS Site Management Module E6(R2) and (R3) Update Supplement Essential Documents for a Clinical Study<br>
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Section 8: “The sponsor and investigator/institution should maintain a record of the location(s) of their respective essential documents including source documents. The storage system used during the trial and for archiving (irrespective of the type of media used) should provide for document identification, version history, search, and retrieval. Essential documents for the trial should be supplemented or may be reduced where justified (in advance of trial initiation) based on the importance and relevance of the specific documents to the trial. The sponsor should ensure that the investigator has control of and continuous access to the CRF data reported to the sponsor. The sponsor should not have exclusive control of those data. When a copy is used to replace an original document (e.g., source documents, CRF), the copy should fulfill the requirements for certified copies. The investigator/institution should have control of all essential documents and records generated by the investigator/institution before, during, and after the trial.”
The investigator/institution should maintain control at all times of essential and source documents. A record detailing the location of documents should be created at the start of the study and updated throughout the trial when applicable. This listing is particularly applicable to documents stored outside of the Investigator Site File (regulatory binder)– for example, the study contract. The investigator should ensure a copy of the eCRF data is received at the end of the study on media with “read only” access. E6(R2) Updates<br>
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Section 2.12.1: "The investigator should ensure that the storage system used during the trial and for archiving (irrespective of the type of media used) provides for document identification, version history, search, and retrieval."
ICH E6(R3) expands upon expectations for the management and control of essential documents, particularly in digital formats. The guidance emphasizes systems that allow for version control, secure access, audit trails, and searchability.
Investigators should:
Maintain a document location record across all systems and storage environments.
Assure that investigator access and control is preserved, especially for CRF/eCRF data.
Understand what constitutes a certified electronic copy and maintain appropriate procedures for archiving, access, and retention. E6(R3) Updates<br>
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This is to certify that:
(insert name)
Has completed reviewing the Topic: ICH E6(R2) and (R3): Guideline for Good Clinical Practice, Essential Documents for a Clinical Study Module Update Supplement, on:
(insert date)
Disclaimer: SCRS does not certify, qualify, endorse, represent or warrant that any clinical trial Investigator or clinical trial site personnel that has completed this Information Program are competent to work on any particular clinical trial or clinical trials generally or are competent to oversee others during clinical trial execution. Certificate of Completion<br>
